Regulatory apparatus

ABSTRACT

A regulatory apparatus for controlling the movement of fluids, cells and energy in conveying structure, as spermatazoa in the ductus deferens or signals in nerve fibers. The regulatory apparatus has a stepped down gear train driven in response to a remote magnetic field to selectively expand and contract a flexible member. A valving device connected to the flexible member is operable to selectively open and close a passageway coupled to the conveying structure in response to the expansion and contraction of the flexible member.

United States Patent [191 Bolduc June 18, 1974 [54] REGULATORY APPARATUS OTHER PUBLICATIONS [75] inventor: Lee Bolduc Minneapolis Minn Kusserow Trans. Amer. Soc. Art Inter. Orgs, 1960, [73] Assignee: Medtronic, Inc., Minneapolis, Minn. PP-

[22] Filed: Aug. 24, 1972 App]. No.: 283,274

[52] US. Cl 128/1 R, 3/1, 128/274, 128/346, 128/D1G. 25 [51] Int. Cl A611) 19/00 [58] Field of Search... 128/1 R, 274, 346, DIG. 25; 3/1

[56] References Cited UNITED STATES PATENTS 2,921,584 1/1960 Di Vette 128/346 3,419,008 12/1968 Plishner 3,575,158 4/1971 Summers..... 3,699,957 10/1972 Robinsonm. 3,704,704 12/1972 Gonzales 128/1 R Primary Examiner-Dalton L. Truluck [5 7] ABSTRACT A regulatory apparatus for controlling the movement of fluids, cells and energy in conveying structure, as spermatazoa in the ductus deferens or signals in nerve fibers. The regulatory apparatus has a stepped down 10 Claims, 6 Drawing Figures REGULATORY APPARATUS BACKGROUND OF THE INVENTION Magnetic couplings have been used to drive devices implantedin the body. Remotely actuated servomechanisms have been developed to control a potentiometer and impart rotary motion to a pump. Bolducin US. Pat. No. 3,569,894 discloses a magnetic servo appara tus having a geartrain for operating a potentiometer. Dorman et al. in US. Pat. No. 3,608,088 shows an exterior remote drive magnet for operating an implanted rotary blood pump. I

At the present time the one certain way for men to prevent conception is to have a vasectomy. This operation is irreversible, as the ductus deferens is severed. Efforts have been made to connect the served ductus deferens with a valve that can be closed to stop the flow of sperm or opened to allow it to flow in the ductus deferns. These valves can only be regulated through a surgical procedure and cannot be remotely operated.

SUMMARY OF THE INVENTION The invention relates to a regulatory apparatus that is implantable in the body of an animal to control the functioning of a bioconveying and biotransmitting means. The regulatory apparatus is responsive to a remote moving magnetic field located outside the body .to effect a control of the conveying means. The regulatory apparatus has a case hermetically enclosing a space. The case has a flexible-means. Enclosed within the space is a first means for selectively expanding and contracting the flexible means. A power transmitting means is connected to the first means for transmitting movement of the first means. The power transmitting means is operated by a magnetic means. The first means, power transmitting means and magnet means are all located within the case means. Located externally of the case means is a second control means operable in response to expansion and contraction of the flexible means to control the functioning of the conveying means. The second means is mounted on the case means and comprises a valve device operable to selectively open and close the conveying means thereby controlling the functioning of the conveying means. The conveying means can be a member having a passageway connected to a duct or canal conveying liquid as blood, lymph, semen or spermatazoaThe conveying means can also be used in conjunction with a chord or nerve fiber to control the transmission of nerve signals.

It is an object of the invention to provide an implantable apparatus which can be operated externally of the body to control the functioning of a conveying means, as the ductus deferens to control the flow of spermatazoa. Another object of the invention is to provide an implantable apparatus with a hermetically sealed case enclosing a power transmitting means operable to actuate a control member located outside of the case.

IN THE DRAWINGS FIG. I is an elevational view, partly sectioned, of the reproductive parts of a male primate having the regulatory apparatus of the invention;

FIG. 2 is an enlarged end view of the regulatory apparatus shown in FIG. 1;

FIG. 3 is an enlarged sectional view taken along the line 3-3 of FIG. 2;

FIG. 4 is an enlarged sectional view taken along the line 4-4 of FIG. 2;

FIG. 5 is a sectional view similar to FIG. 4 of a modification of the valving device of the regulatory apparatus; and

FIG. 6 is a side elevational view of a modified regulatory apparatus of the invention.

Referring to the drawings, there is shown in FIG. 1 the reproductive parts of a male primate indicated generally at 10. The drawings are in diagram form to facilitate understanding the invention and are not to any scale. The scale varies from one view to another. For example, the remote actuator 17 hereinafter described can be much larger in size than the implanted regulatory apparatus 16. Parts 10 are shown by way of example only as the regulatory apparatus 16 of the invention can be used not only in male and female humans but in animals and fowl and like creatures. Parts 10 include the male reproductive glands or testes l1 and the ductus deferens 12, which functions as a vas or duct for carrying the male gamete or spermatazoa from gland 11 to the ejaculatory duct. Gland 11 and duct 12 are located in a musculocutaneous sac or scrotum 13 formed of skin and a network of muscular fibers. The regulatory apparatus 16 can be located in other body cavities and used to control the flow of ovum in the uterine tube of a female. Signals in selected nerve fibers can also be controlled with the regulatory apparatus to restrict and temporarily block transmission of nerve signals. The invention is hereinafter described as relating to the control of spermatazoa in the ductus deferens, it being understood that the regulatory apparatus is useable asa control in other parts of the anatomy. Two regulatory apparatuses can be used with the two ductus deferens. Alternatively, one ductus deferens can be severed.

Implanted within scrotum 13 is the regulatory apparatus of the invention indicated generally at 16. Apparatus 16 is a device operable to selectively close and open the passage of the ductus deferens 12, thereby controlling the emission of spermatazoa. When the ductus deferens is closed for both testes it is impossible to have zygosis with an ovum.

Referring to FIG. 3, the regulatory apparatus 16 has a cup-shaped case or housing 18 having an outwardly directed annular lip 19 at the open end thereof. Case 18 is formed from a rigid material which is electrically insulative and biologically inert, as ceramic material, polycarbonate resin or polypropylene. Case 18 can also be formed from stainless steel or titanium. A flexible diaphragm 21 is hermetically sealed to lip 19 to form a sealed chamber 22 within housing 18 impervious to body fluids and tissue. A power transmitting apparatus 23 located in chamber 22 has a pair of spaced plates24 and 25 carrying a stepped down gear train 26. Preferably, the gear train 26 has a power ratio of 150021. Other gear ratios can be used. The gear train 26 is illustrated as a spur gear assembly having a plurality of interengaging gears. Other types of gear mechanisms, such as planetary gears, can be used for the gear train. Lubricant, as oil, is contained within the hermetically sealed housing 18 for the power transmitting means. Plate 24 is in engagement with an annular sleeve 27 spacing the plate from diaphragm 21. Opposite: plate 25 engages an annular sleeve 28 which rests on the bottom wall of the 3 housing. Sleeves 27 and 28 are preferably of nonmagnetic, electrically insulative material such as polyethylene, Nylon, Teflon or Delrin- Power transmitting apparatus 23 has power input shaft 29 carrying outwardly directed rod magnets 31 and 32. The magnets are formed from a high energy magnetic material as iron-aluminum-nickel-cobalt-copper alloys or magnetic platinum-cobalt alloys. Magnet 31 has a south polarity. Magnet 32 has a noth polarity. Concentrically aligned with input shaft 29 is an output shaft 33. Bearings 34 on plate 24 rotatably mount the output shaft 33. Output shaft 33 has a threaded head 36. Head 36 is threaded into a nut or sleeve 37 secured to the center portion of the inside of diaphragm 21. The head 36 and sleeve 37 are cooperating means operable to move the diaphragm 21. Head 36 can be a cylindrical member or sleeve that is threaded onto a bolt-like member secured to the center portion of the inside of diaphragm 21. The cooperating threaded members 36 and 37 can be lo cated within the confines of gear train 26 between plates 24 and 25 to reduce the overall height of the housing 18.

A control or valve device indicated generally at 38 is mounted on the housing 18 adjacent the outside of diaphragm 21. Valve device 38 has a support 39. Device 38 and support 39 can be enclosed with a cover to prevent fibrosis around the device. As shown in FIG. 2, support 39 extends across the midsection of diaphragm 21. The center portion of support 39 carries a holder or body 41 having a transverse passage 42. Extended through passage 42 is an elongated tubular member 43. Member 43 is made of flexible material that can be closed or collapsed and will return to its open position. For example, member 43 can be a silicone rubber tube. Opposite ends of tubular member 43 extend outwardly in opposite directions from the body 41 and carry the ductus deferens 12, whereby the tube 43 provides a continuous passage for the spermatazoa. A body 41 has a stem 44 carrying a nut 46 operable to secure the body to support 39. Stem 44 has a passage carrying a movable plunger or valving element 47. As shown in FIGS. 3 and 4, valving element 47 is secured to the center portion of the flexible diaphragm 21 in alignment with the axis of nut 37. The outer end of plunger 47 engages the flexible tube 43 and is movable in the opposite direction, as indicated by arrow 48, to a position to close the passage and tube 43, shown by broken lines in FIG. 3, and to open the passage, as shown in full lines in FIG. 3. Body 41 can be an integral part of support 39.

In operation, the regulatory apparatus 16 is surgically implanted in the body cavity shown in FIG. 1 and connected to the ductus deferens 12. Housing 18 and diaphragm 21 are hermetically sealed together whereby the chamber 22 is not affected by body fluids or other corrosive media, tissue ingrowth and the like. The remote actuator 17 includes a motor 66 having a rotatable shaft 67. A magnet 68 is secured to shaft 67 and is rotated on operation of motor 66. Magnet 68 is shown as a bar magnet having a north pole and a south pole. Motor 66 can be a reversible type and have switch means for selecting its direction of rotation. Motor 66 is enclosed in housing 69. Suitable counting means (not shown) may be attached to the motor 66 or shaft 67 to count the number of turns in either direction of rotation of the magnet 68.

On energization of motor 66, the shaft 67 rotates magnet 68. The actuator 17 is held in close proximity to the regulatory apparatus 16, as shown in FIG. 1, to provide a magnetic coupling. There is no physical connection between the actuator 17 and regulatory apparatus 16. The moving flux lines or magnetic force of magnet 68 will affect magnets 31 and 32 to cause rotation of shaft 29. The rotation of input shaft 29 will transmit force via the power transmitting apparatus 23 to the output shaft 33. The rotation of output shaft 33 will turn the threaded head 36 relative to the fixed nut 37. The relative rotation between head 36 and nut 37 will cause the diaphragm to move outwardly, as shown in broken lines, or inwardly depending on the direction of drive of input shaft 29. When the motor 56 is operated in a forward direction, the threaded head 36 will rotate to flex the diaphragm 21 in an outward direction, as shown by broken lines in FIG. 3. This moves the plunger 47 in an outward direction, flexing tube 43 to the closed or blocked position, shown in broken lines in FIG. 3. This will cut off the flow of spermatazoa through the ductus deferens 12.

In the event it is desired to resume the flow of spermatazoa through the ductus deferens 12, the regulatory apparatus 16 can be actuated to its open position with remote actuator 17. Motor 16 is operated in a reverse or off direction, thereby rotating magnet 68 in a direction which will reverse the power transmitting apparatus 23 and rotate the threaded head 36 in a direction which will move the flexible diaphragm back to its initial position in the cavity 22, shown in full lines in FIG. 3. Plunger 46, being attached to the diaphragm, will retract away from tube 43. Tube 43, being of a flexible material, will move back to its initial open position, thereby allowing the flow of spermatazoa in the ductus deferenes 12.

Referring to FIG. 5, there is shown a modification of a valve device, indicated generally at 50, for accommodating a plurality of tubes 54 and 56. The structure is identical in the valve device 50 and the regulatory apparatus is indicated with the same reference numerals having the suffix A. The valve device has a body or holder 51 having a pair of generally aligned passages 52 and 53 for carrying tubes 54 and 56. Body 51 has a stem 57 extended through the hole in support 39A. A nut 58 threaded on the stern holds the body in assembled relation with support 39A. Secured to the center portion of diaphragm 21A are a pair of plungers 61 and 62. Plungers 61 and 62 can be attached to a cross member pivotally connected to the diaphragm. Plunger 61 has an outer end that extends into a passage in body 51 and is engageable with tube 54. In a similar manner, plunger 62 has an outer end extended into passage 53 and is engageable with tube 56. On rotation of threaded head 36A, flexible diaphragm 21A can move in opposite directions as indicated by arrow 63. When 36A is rotated in a first or forward direction, the plungers 61 and 62 move into engagement with tubes 54 and 56, flexing the tubes and thereby blocking the passage in the tubes to prevent the flow of spermatazoa. On operation of the threaded head 36A in the opposite direction, flexible diaphragm 21A moves away from the body, thereby carrying the plungers 61 and 62 away from tubes 54 and 56, thereby opening the passages in the tubes.

Referring to FIG. 6, there is shown a modification of the regulatory apparatus indicated generally at 70. Apparatus has a hermetically sealed housing 71. The outer circumferential wall of the housing has an accordion or corrugated shape which will allow longitudinal expansion and contraction of the housing side wall on operation of the gear train and jack screw mechanism hermetically sealed within the housing. Mounted on one end of the housing is a valve device 72 similar to the valve device 38 shown in FIG. 4 for carrying a tube 73. On operation of the regulatory apparatus 70 with the use of a remote actuator similar to actuator 17, the side wall of housing 71 will expand, thereby effectuating a closing of valve device 72. On operation of the re mote actuator in the opposite direction, the side wall of housing 71 will contract, thereby opening valve device 1 The above description relates to preferred embodiments of the invention; however, it is understood that various other embodiments and changes in size, material, power transmission means and valving mechanisms may be made by those skilled in the art without departing from the spirit of the invention. Furthermore, the invention is not intended to be particularly limited to the control of spermatazoa in the ductus deferens of a male primate. The invention is useable with other vas, ducts or canals carrying fluids such as blood, lumph and the like. Also, the invention is useable with other biocontrol means,'as nerve fibers and can function to temporarily restrict and block impulses in nerve fibers.

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. An apparatus for implantation in the body of an animal operable to control the functioning of a body fluid conveying means and being responsive to a remote moving magnetic field comprising: case means hermetically enclosing a space, said case means having imperforate flexible wall means having an inside surface and outside surface at one portion of the case means, first means for selectively expanding and contracting said flexible wall means, said'first means including a first member attached to the inside surface of said flexible wall means and a second member threadably engaged with the first member, said second member being rotatable to selectively axially move the first member to thereby selectively expand and contract said flexible wall means, .power transmission means connected to said second member for transmitting rotational motion to the second member, magnet means connected to the power transmission means, said magnet means being responsive' to the remote moving magnetic field to operate the power transmission means, said first means, power transmission means and magnet means being located within the case means and valve means secured to the case means externally of the case means, said valve means having tubular means connected to the body fluid conveying means and plunger means secured to the outside surface of said flexible wall means and engageable with the tubular means, said plunger means movable in response to expansion and contraction of the flexible wall means to selectively open and close the tubular means to control the functioning of the body fluid conveying means.

2. The apparatus of claim I wherein: said flexible wall means is a flexible diaphragm.

3. The apparatus of claim 1 wherein: said flexible wall means is a flexible diaphragm located across one end of the case means, said second member being attached to a center portion of the diaphragm.

4. The apparatus of claim 1 wherein: the first member includes a sleeve secured to the wall means, said sleeve having a threaded bore, said second member having a head threaded into said threaded bore.

5. The apparatus of claim 1 wherein: said case means includes an expandable and contractable side wall.

6. The apparatus of claim 1 wherein: said power transmission means is a stepped down gear train having an input shaft connected to the magnet means and an output shaft connected to the second member. 7

7. The apparatus of claim 1 wherein: said magnet means comprises at least one bar magnet having north and south magnetic poles at opposite ends thereof.

8. The apparatus of claim 1 wherein: the valve means has a body secured to the case means, said body having a passage accommodating the plunger means to control the functioning of the conveying means.

9. The apparatus of claim 8 wherein: the valve means has a pair of tubular members connected to the conveying means, said plunger means having a pair of movable members secured to the flexible wall means, one of said movable members being engageable with one tubular member and the other movable member being engageable with the other tubular member, said movable members being responsive to expansion movement of the flexible wall means to collapse the tubular members and responsive to contraction of said flexible means to permit the tubular members to open.

10. The apparatus of claim 1 including: means securing the valve means to the case means, said valve means having a tubular member connected to the conveying means, and a body having a passage accommodating the plunger means whereby said plunger means is engageable with the tubular member so that on expansion of the flexible wall means, the plunger means closes the tubular member and on contraction of the flexible wall means the plunger means permits the tubular member to open.

*;g;;g UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 3 7 2 37 Dated June 18 1974 lnuent0r(s) Lee R. Bolduc It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:

Column 3 line 9, "noth" should be north-;

Column 4 line 34, "deferenes" should be --deferens;

Column 5, I line 23, "lumph" should be -lymph--.

Signed and sealed this 17th day of September 1974.

(SEAL) Attest: I

MCCOY M. GIBSON JR. c. MARSHALL DANN Attesting Officer Commissioner of- Patents 

1. An apparatus for implantation in the body of an animal operable to control the functioning of a body fluid conveying means and being responsive to a remote moving magnetic field comprising: case means hermetically enclosing a space, said case means having imperforate flexible wall means having an inside surface and outside surface at one portion of the case means, first means for selectively expanding and contracting said flexible wall means, said first means including a first member attached to the inside surface of said flexible wall means and a second member threadably engaged with the first member, said second member being rotatable to selectively axially move the first member to thereby selectively expand and contract said flexible wall means, power transmission means connected to said second member for transmitting rotational motion to the second member, magnet means connected to the power transmission means, said magnet means being responsive to the remote moving magnetic field to operate the power transmission means, said first means, power transmission means and magnet means being located within the case means and valve means secured to the case means externally of the case means, said valve means having tubular means connected to the body fluid conveying means and plunger means secured to the outside surface of said flexible wall means and engageable with the tubular means, said plunger means movable in response to expansion and contraction of the flexible wall means to selectively open and close the tubular means to control the functioning of the body fluid conveying means.
 2. The apparatus of claim 1 wherein: said flexible wall means is a flexible diaphragm.
 3. The apparatus of claim 1 wherein: said flexible wall means is a flexible diaphragm located across one end of the case means, said second member being attached to a center portion of the diaphragm.
 4. The apparatus of claim 1 wherein: the first member includes a sleeve secured to the wall means, said sleeve having a threaded bore, said second member having a head threaded into said threaded bore.
 5. The apparatus of claim 1 wherein: said case means includes an expandable and contractable side wall.
 6. The apparatus of claim 1 wherein: said power transmission means is a stepped down gear train having an input shaft connected to the magnet means and an output shaft connected to the second member.
 7. The apparatus of claim 1 wherein: said magnet means comprises at least one bar magnet having north and south magnetic poles at opposite ends thereof.
 8. The apparatus of claim 1 wherein: the valve means has a body secured to the case means, said body having a passage accommodating the plunger means to control the functioning of the conveying means.
 9. The apparatus of claim 8 wherein: the valve means has a pair of tubular members connected to the conveying means, said plunger means having a pair of movable members secured to the flexible wall means, one of said movable members being engageable with one tubular member and the other movable member being engageable with the other tubular member, said movable members being responsive to expansion movement of the flexible wall means to collapse the tubular members and responsive to contraction of said flexible means to permit the tubular members to open.
 10. The apparatus of claim 1 including: means securing the valve means to the case means, said valve means having a tubular member connected to the conveying means, and a body having a passage accommodating the plunger means whereby said plunger means is engageable with the tubular member so that on expansion of the flexible wall means, the plunger means closes the tubular member and on conTraction of the flexible wall means the plunger means permits the tubular member to open. 